Apparatus for the removal of adherent viscoelastic

ABSTRACT

A method and apparatus is disclosed for the removal of viscoelastic material from an eye chamber. The apparatus enables a procedure, or method, which includes the steps of directing an irrigation fluid toward a viscoelastic material disposed in an eye chamber in order to loosen said viscoelastic material from eye chamber surfaces, hydraulically forcing the loosened viscoelastic material from the chamber surfaces, and aspirating the loosened viscoelastic material from the eye chamber.

This is a continuation of prior U.S. patent application Ser. No.08/056,373, filed on Apr. 30, 1993, now U.S. Pat. No. 5,358,473.

The present invention generally relates to surgical instruments and moreparticularly to needle apparatus and a method for removal ofviscoelastic material from an eye chamber.

In many ophthalmic surgical procedures such as, for example, intraocularlens implantation, cataract surgery and retinal detachment repair, aviscous gel-like composition is utilized to fill the chambers of the eyein order to protect sensitive tissue, in particular the corneaendothelium from trauma.

While many compositions have been utilized, commonly employedcompositions include solutions of hyaluronic acid, chondroitin sulfateand methylcellulose. The many various viscoelastic materials heretoforeused for this purpose may be classified as either adhesive viscoelastic,such as Viscoat®, or cohesive viscoelastic, such as Healon®.

Adhesive viscoelastic materials are effective in coating the endotheliumwell and further resist washout during phaco surgery, which includes theirrigation of the eye chamber with balanced saline solution (BSS).

Unfortunately, adhesive viscoelastic materials are difficult to removebecause, while being adhesive, they are not cohesive, that is, they donot intend to hold together, but preferentially, adhere to eye surfaces.This is particularly troublesome in conventional eye surgery in whichthe viscoelastic material is aspirated at completion of surgery.

Such aspiration is required because retained viscoelastic materialcauses elevated intraocular pressure. Unless a complete removal of theviscoelastic material at the end of the operation is effected, postoperative intraocular pressure may be increased.

As briefly hereinabove mentioned, a desirable viscoelastic material foreye surgery, including phacoemulsification, sticks, or adheres, to thetissues in the eye with greater adherence than it sticks to itself.Thus, it is not easily dislodged by turbulence. This is of particularimportance when the adhesive viscoelastic material must be removed fromareas such as anterior chamber angle, sulcus and the capsular bag behindthe intraocular lens which are not easily accessible to currentinstrumentation. Thus, it is apparent that the same adhesive propertythat provides the best coating for endothelium during surgery also makesit difficult to remove the material at the end of the operation.

Alternative materials, which may be classified as cohesive, viscoelasticmaterials, such as Healon, hereinabove noted, are easily aspirated orirrigated out enmass since they adhere, or stick, to themselves.(Cohesive property). Unfortunately, such cohesive viscoelastic materialsare not preferred by surgeons because they do not adhere to thesensitive tissue, to be protected, as well as the adhesive viscoelasticmaterials.

Heretofore utilized irrigation/aspiration instruments for use in eyesurgery have utilized needles suitable for singly irrigating, andaspirating the eye chamber. The heretofore irrigation has been performedusing a gradual flow of BSS for the sole purpose of replacing the fluidsbeing pumped out or leaking out of the eye chamber.

The apparatus and method of the present invention enables a use of thepreferred adhesive viscoelastic materials in ophthalmic surgeryprocedures.

SUMMARY OF THE INVENTION

The method in accordance with the present invention for the removal ofviscoelastic material from the eye chamber, generally includes the stepsof directing an irrigation fluid toward a viscoelastic material disposedin an eye chamber in order to loosen the viscoelastic material fromchamber surfaces. This step provides a gentle jet of fluid irrigation tosweep adhesive viscoelastic material off surfaces.

Secondly, in accordance with the method of the present invention, theloosened viscoelastic material is hydraulically forced from the chambersurfaces, in particular, narrow spaces in the anterior chamber.Thereafter, the loosened viscoelastic material is aspirated from the eyechamber.

In accordance with the method of the present invention, the steps ofdirecting an irrigation fluid and aspirating the loosened viscoelasticmaterial may be performed simultaneously. This must be contrasted with aprior art procedures and apparatus which are designed for separatelyirrigating the eye chamber and sequentially aspirating viscoelasticmaterial therefrom.

The method of the present invention is particularly advantageous sinceadhesive viscoelastic material cannot be easily pulled, or aspirated,out of many narrow areas in the eye chamber. Further continuedasperation in accordance with the prior art merely removes theirrigation fluid.

Thus, the present invention provides a continuous sweep of fluid withcontrolled removal of a volume of loosened material from an eye chamber.

More particularly, a method in accordance with the present inventioncomprises the step of circulating the loosened viscoelastic materialfrom the eye surface to an aspiration port with the irrigation fluid.

Preferably, the irrigation fluid is directed toward the viscoelasticmaterials in the form of a jet. This must be contrasted with the priorart devices which only provide a diffused introduction of irrigationfluid into an eye chamber for the purpose of maintaining eye chamberpressure and for flushing fragmented crystaline lens for example, fromthe eye chamber.

More specifically, a plurality of irrigation fluid jets may be providedfor loosening and circulating viscoelastic material from surfaces on theeye chamber and the loosened viscoelastic material is aspirated leewardfrom the directed irrigation fluid.

The apparatus in accordance with the present invention generallyincludes means for directing an irrigation toward a viscoelasticmaterial disposed in an eye chamber in order to loosen the viscoelasticmaterial from the eye surface and hydraulically forcing the loosenedviscoelastic material from the chamber surfaces along with means foraspirating the loosened viscoelastic material from the eye chamber.

More particularly, the apparatus in accordance with the presentinvention, includes a needle having means defining a first lumen thereinfor accepting irrigation fluid and means defining a first irrigationport in the needle, for emitting the irrigation fluid from the firstlumen at a first angle to a longitudinal needle axis. A secondirrigation port may be provided in the needle for emitting of theirrigation fluid from the first lumen at a second angle to the needleaxis. The emission of irrigation fluid from the first and secondirrigation ports may be in a single plane which is perpendicular to theneedle axis.

Means may be provided which define a second lumen in the needle foraspirating the loosened viscoelastic material and irrigation fluid,which includes an aspiration port in fluid communication with the secondmeans for receiving the loosened viscoelastic material at a third angleto the needle axis.

In one embodiment of the present invention, the first and second lumensare disposed in a parallel relationship, while in another embodiment ofthe invention, the first and the second lumens are coaxially disposedwithin the needle.

The apparatus of the present invention further includes, in combination,an adhesive viscoelastic material and a needle which includes means fordirecting an irrigation fluid toward the viscoelastic material disposedon an eye chamber surface in order to loosen the viscoelastic materialand hydraulically force the loosened viscoelastic material from the eyechamber surface along with a means for aspirating the viscoelasticmaterial from the eye chamber.

In addition, the method of the present invention is useful in ophthalmicsurgery includes the steps of coating sensitive eye tissue in an eyechamber with an adhesive viscoelastic material and thereafter directingan irrigation fluid toward the viscoelastic material in order to loosenthe viscoelastic material from the sensitive eye tissues andhydraulically force the loosened viscoelastic material from thesensitive eye tissues and aspirating the loosened viscoelastic materialfrom the eye chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

The advantages and features of the present invention will appear fromthe following description, when considered in conjunction with theaccompanying drawings in which:

FIG. 1 is a cross-sectional view of apparatus in accordance with thepresent invention, suitable for carrying out the method of the presentinvention;

FIG. 1A is a cross-sectional end view of the embodiment shown in FIG. 1;

FIG. 2 is a cross-sectional view of a second embodiment of the presentinvention utilizing one irrigation port and two aspiration ports;

FIG. 2A is an end view of the embodiment shown in FIG. 2;

FIG. 3 is an alternative embodiment of the present invention showingcoaxial lumens;

FIG. 3A is an end cross-sectional view of the embodiment shown in FIG.3;

FIG. 4 is yet another alternative embodiment of the present invention;

FIG. 4A is an end view of the embodiment shown in FIG. 4;

FIGS. 5 and 6 are representations of the method of the present inventionshowing the loosening of a viscoelastic material by irrigation fluid,hydraulic forcing of the loosened vascular material from chambersurfaces and aspiration thereof from the eye chamber; and

FIG. 7 is a representation of the prior art utilizing aspiration onlyfor the removal of adherent viscoelastic material.

DETAILED DESCRIPTION

Turning now to FIG. 1, there is generally shown apparatus 10 inaccordance with the present invention for the removal of viscoelasticmaterial from an eye chamber, which specifically includes a needle 14including an irrigation lumen 18 therein and an aspiration lumen 20therein.

Only a tip portion 24, the needle 14 is shown, the tip portion 24 beingcoupled in a conventional manner with a conventionalirrigation/aspiration handpiece providing irrigation fluid to theirrigation lumen 18 and the suction to the aspiration lumen 20. Theconventional phaco handpiece and coupling device for securing the needle14 thereto are not part of the present invention and therefore not shownfor the sake of clarity.

An irrigation port 30 is disposed in a portion 32 of the irrigation side36 of the needle 14 protruding past an aspiration side 40 of the needle14. An opposing aspiration port 44 is disposed in the aspiration side 40of the needle 14 facing in opposing direction to the irrigation port 30.The operation of this device will be hereinafter described in greaterdetail.

FIG. 1A is an end view of the embodiment shown in FIG. 1, FIGS. 2 and 2Aare views of an alternative embodiment similar in all respects to theneedle 14 as shown in FIG. 1, except that two opposing aspiration ports48, are utilized.

Alternative embodiments of the present invention are shown in FIGS. 3,3A, 4 and 4A. FIG. 3 shows a needle 54 having coaxial irrigation lumen56 and aspiration lumen 58 and extended tip 62 communicating with theirrigation lumen 56 includes an irrigation port 64 and an outer sleeve66 includes an aspiration port 68 communicating with the aspirationlumen 58. As shown in both FIGS. 3 and 3A, the aspiration port 68 andirrigation port 64 face in opposite directions and the operation thereofwill be hereinafter described in greater detail.

Turning now to FIG. 4, there is yet another embodiment 72 of a needle 74in accordance with the present invention, having an inner aspirationlumen 78 and an outer irrigation lumen 80 in a coaxial relationship. Inthis embodiment, a tip 84 protrudes from the needle 74 and includes anaspiration port 88 in fluid communication with the aspiration lumen 78.In this instance, the port 88 is disposed in the tip of 84 at a positionso that the aspiration of fluids into the aspiration lumen 78 occurs atan acute angle A to a longitudinal axis 92 with the needle 74. As bestshown in FIG. 4A, two irrigation lumen ports 96, 98 are provided in linefor emitting irrigation fluid in a plane 100, which may be perpendicularto the longitudinal axis 92.

As also shown in FIG. 4a, the aspiration port 88 may be disposed about135 degrees from each irrigation ports 96, 98.

In operation, the plurality of the irrigation ports 96, 98 disposed atapproximately 90 degrees from one another, enables manual rotation ofthe needle 74 to provide a greater degree of access to narrow orrelatively remote portions of the eye chamber for the flushing ofadherent vasoelastic material thereoutof. That is, a rotation of 45degrees as shown by the double headed arrow B in FIG. 4A enablesirrigation from the Ports 96, 98 to be directed over a 180 degree range.

In order to provide a proper supply of irrigation fluid which isdirected from the needle 74, the irrigation ports may be between about0.3 and about 0.5 mm diameter. It has also been found that an aspirationport diameter in the range of about 0.2 to about 0.3 mm is sufficientfor aspirating fluid and loosened adherent viscoelastic material fromthe eye chamber.

The advantages of the hereinabove described apparatus and description ofthe method in accordance with the present invention may be moreappreciated when taken in consideration of the representation shown inFIGS. 5 and 6.

In FIG. 5, the needle 14 is shown inserted into an eye chamber and anirrigation of fluid is directed toward adherent viscoelastic material110 in the form of a gentle jet 106 which causes penetration 112 by theirrigation fluid which, after continued irrigation, as shown in FIG. 6,the jet 106 lifts the adherent viscoelastic material 110 from an eyechamber surface 114 and hydraulically forces the loosened material 118,causing breakup thereof, so that it may be aspirated by the port 44leeward from the jet 106. That is, in a direction opposite or away fromthe direction of the jet 106.

While the embodiment of the present invention shown in FIG. 1 isillustrated in FIGS. 5 and 6, any of the other embodiments of thepresent invention may be utilized and the operation thereof consistentwith the presentation shown in FIGS. 5 and 6.

The apparatus method of the present invention must be contrasted withthat of the prior art as shown in FIG. 7. A needle 122 therein havingone or more lumen therein are utilized for irrigation and aspiration.One or more ports 124 provide a diffuse irrigation stream not suitablefor hydraulically loosening and forcing loosened viscoelastic from aneye chamber surface 126, as is the case with the present invention.

As hereinbefore pointed out, the adherent nature of preferredviscoelastic material inhibits the removal thereof of eye surfaces 126.Therefore, the diffuse irrigation provided by the prior art does notadequately remove the adhesive viscoelastic material.

As shown during aspiration of the material 110, it breaks into smallerpieces 130 in the immediate vicinity of the needle 122, since thematerial 110 adheres to surfaces 126 more than it does to itself

Thus, in the prior art device, an attempt to aspirate, or pull, thematerial 110 from the surface, inevitably results in removal of only theadjacent material 110, which necessitates the scavenging of all interiorsurfaces to obtain total removal of the viscoelastic material 110. Thisnecessitates an unnecessarily long and hazardous procedure in order toremove all of the viscoelastic elastic material 110 from the area suchas the anterior chamber angle, ciliary sulcus and the capsular bagbehind the intraocular lens.

The present invention, as illustrated in FIGS. 5 and 6, facilitates theremoval of the viscoelastic material 110 by sweeping the material 110off surfaces 114 and hydraulically forcing it out of the narrow spacesinto the anterior chamber where the loosened material 118 is easilyaspirated. That is, in effect, the viscoelastic material 110 is pushedfrom the surfaces 114 rather than being sucked, or aspirated therefrom,as has been the case with prior art apparatus and procedures.

Although there has been hereinabove described apparatus and method forthe removal of viscoelastic material from an eye chamber in accordancewith the present invention, for the purpose of illustrating the mannerin which the invention may be used to advantage, it should beappreciated that the invention is not limited thereto. Accordingly, anyand all modification, variations, or equivalent arrangements which mayoccur to those skilled in the art should be considered to be within thescope of the present invention as defined in the appended claims.

What is claimed is:
 1. Apparatus for the removal of viscoelasticmaterial from an eye chamber, said apparatus comprising:first irrigationport means for directing a jet fluid toward a viscoelastic materialdisposed in an eye chamber to first penetrate said viscoelastic materialand thereafter loosen said viscoelastic material from the chambersurfaces without substantial breakup of the viscoelastic material andhydraulically forcing by pushing the loosened viscoelastic material fromthe eye chamber surfaces without substantial breakup of the viscoelasticmaterial, said first irrigation port means comprising an opening havinga diameter of between about 0.3 mm and about 0.5 mm; and aspiration portmeans for aspirating the loosened viscoelastic material from the eyechamber.
 2. The apparatus according to claim 1 further comprising aneedle having first lumen means, in fluid communication with saidirrigation port means, for accepting said irrigation fluid, said firstirrigation port means being disposed in said needle at a position foremitting the jet of irrigation fluid from said first lumen means at afirst angle to a longitudinal needle axis.
 3. The apparatus according toclaim 2 further comprising second irrigation port means, disposed insaid needle, for emitting a second jet of irrigation fluid from saidfirst lumen means at a second angle to the needle axis.
 4. The apparatusaccording to claim 3 wherein the first and second irrigation port meansare aligned for emitting irrigation fluid on a plane.
 5. The apparatusaccording to claim 4 wherein said plane is perpendicular to the needleaxis.
 6. The apparatus according to claim 5, wherein the aspiration portmeans comprises an aspirating port and a second lumen, said aspirationport being disposed at a third angle to the needle axis.
 7. Theapparatus according to claim 6 wherein said first and second lumen meansare coaxially disposed within said needle.
 8. The apparatus according toclaim 7 wherein the first and second irrigation port means are disposedat about 90 angular degrees from one another.
 9. The apparatus accordingto claim 8 wherein said aspirating port means is disposed at about 135angular degrees from each of the irrigating port means.
 10. Theapparatus according to claim 6 wherein said first and second lumen meansare disposed in a parallel relationship within said needle.